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NCT05087108 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of the OsciPulse Rapid Cycling Compression Device Effects on Venous Blood Flow
A Early Phase 1 study of Venous Stasis and Venous Thromboses, sponsored by OsciFlex.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05087108: Completed Early Phase 1 study of Venous Stasis and Venous Thromboses, sponsored by OsciFlex.
NCT05087108 is a Early Phase 1 study of Venous Stasis and Venous Thromboses that has completed, run by OsciFlex. The registered enrollment target is 16 participants, below the 198-participant average among 6 other Venous Stasis trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05087108, a Early Phase 1 study of Venous Stasis and Venous Thromboses, has completed, sponsored by OsciFlex.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the effects on venous blood flow of the investigational device, OsciPulse system, which is an external intermittent limb compression device. The study will enroll healthy human subjects who will have their deep venous blood flow measured by vascular ultrasound during immobility, use of the OsciPulse system, and use of two reference vascular compression devices. Our hypothesis is that the OsciPulse system will create distinct patterns of venous flow, specifically at the site of venous valves, in comparison to the reference compression devices.
Primary Outcome
The volume flow index (mL/mL) will be measured for flow in the valve sinus region that is moving back towards the heart (forward flow). The venous flow at a valve will be measured using 2D color Doppler ultrasound, and flow volume index calculated from the resulting video clips.
Conditions Studied
Interventions
- DEVICE OsciPulse system
- DEVICE Reference Therapy 1
- DEVICE Refence Therapy 2
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-03-17 |
| Est. Completion | 2022-06-30 |
| Phase | Early Phase 1 |
What the finished NCT05087108 record still lists
NCT05087108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 198-participant average among 6 other Venous Stasis trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Venous Stasis appearing as the primary indexed condition, and to 3 interventions - of which OsciPulse system is the first listed.
NCT05087108 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05087108 about?
NCT05087108 is a clinical study titled "Evaluation of the OsciPulse Rapid Cycling Compression Device Effects on Venous Blood Flow". This study will evaluate the effects on venous blood flow of the investigational device, OsciPulse system, which is an external intermittent limb compression device. The study will enroll healthy human subjects who will have their deep venous blood flow measured by vascular ultrasound during immobil...
What is the current status of trial NCT05087108?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2022-03-17. Estimated completion is 2022-06-30.
What conditions does trial NCT05087108 study?
This clinical trial studies the following conditions: Venous Stasis, Venous Thromboses.
What interventions are being tested in trial NCT05087108?
The interventions under investigation include: OsciPulse system (DEVICE), Reference Therapy 1 (DEVICE), Refence Therapy 2 (DEVICE).
Who is sponsoring clinical trial NCT05087108?
This trial is sponsored by OsciFlex, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05087108 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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